Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Brainsway.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Brainsway
ClinicalTrials.gov Identifier:
NCT01361815
First received: May 26, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

The purpose of the study is to explore the Tolerability and Safety of the H-Coil deep Transcranial Magnetic Stimulation (TMS) in combination with Serotonin Selective Reuptake Inhibitor (SSRI) for Subjects with Major Depression Disorder (MDD) who Complete/ Discontinued the Deep TMS Multicenter study for Subjects with Major Depression Disorder (MDD) (Protocol# CTP-0001-00).


Condition Intervention Phase
Major Depressive Disorder, Recurrent, Unspecified
Major Depressive Disorder, Single Episode, Unspecified
Other: H-Coil Deep TMS in combination with SSRIs
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Trial to Explore the Tolerability and Safety of the H-Coil Deep TMS in Combination With Serotonin Selective Reuptake Inhibitor(SSRI) for Subjects With MDD Who Complete/ Discontinued the CTP-0001-00 Protocol

Resource links provided by NLM:


Further study details as provided by Brainsway:

Primary Outcome Measures:
  • The tolerability and safety of H-coil deep rTMS treatment in combination with SSRI medications [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    Safety:

    AE incidence, Vital signs, Physical and neurological examination, Young Manic Rating Scale (YMRS), Suicide Ideation Scale (SSI)

    Tolerability:

    Number of subjects (%) who discontinue the study, Number of subjects (%) who discontinue the study due to AEs



Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
H-Coil Deep TMS Treatment Other: H-Coil Deep TMS in combination with SSRIs
The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
Other Name: H-Coil Deep TMS Treatment

  Eligibility

Ages Eligible for Study:   22 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Men and women 22-68 years of age
  • Primary DSM-IV diagnosis of Major Depression, single or recurrent episode confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV).
  • Completed the CTP-0001-00 study according to the protocol, i.e., either completed 16 weeks of treatment, or were discontinued from the CTP-0001-00 study protocol after 6 weeks or more from randomization.
  • Capable and willing to provide informed consent.
  • Able to adhere to the treatment schedule.

Exclusion Criteria:

  • Discontinued from CTP-0001-00 study protocol due to the following reasons: Tolerability and safety reason, Non-compliant with the study protocol, Developed documented suicidal ideation as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or suicidal attempt
  • Current psychotic disorder
  • Sensitivity or allergic or other severe adverse event previously reported for Citalopram, Escitalopram, Fluoxetine, Paroxetine, or Sertraline.
  • Known or suspected pregnancy
  • Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
  • Minimal MT found for both hands is higher than 75% of stimulator power output.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361815

Locations
United States, California
University of California (UCLA)
Los Angeles, California, United States, 90095
UC Davis Center for Mind & Brain
Sacramento and Davis, California, United States, 95817
Smart Brain and Health
Santa Monica, California, United States, 90403
United States, Florida
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States, 33408
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States, 33411
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
McLean Hospital - TMS Services
Belmont, Massachusetts, United States, 02478
United States, New Hampshire
Greater Nashua Mental Health Center
Nashua, New Hampshire, United States, 03060
United States, New York
Columbia University / New York State Psychiatric Institute
New-York, New York, United States, 10032
Neuropharmacology Services
New-York, New York, United States, 10021
United States, North Carolina
Duke Medical Center Department of Psychiatry & Behavioral Sciences
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
United States, Texas
Senior Adults Specialty Research
Ausitn, Texas, United States, 78757
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8898
Canada, Ontario
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
France
EPS Ville-Evrard
Neuilly Sur Marne, France, 93332
Germany
Universitätsklinikum Bonn, Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, Germany
Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universität
Munich, Germany
Israel
Beer Yaacov Mental Health Center
Beer Yaacov, Israel
Shalvata Mental Health Center
Hod Hasharon, Israel
Hadasah Ein-Karem Medical Center
Jerusalem, Israel
Kfar Shaul Mental Health Center
Jerusalem, Israel
Sponsors and Collaborators
Brainsway
Investigators
Principal Investigator: Abraham Zangan, Prof. Weizmann Institute of Science
Principal Investigator: Yechiel Levkovitz, Prof. Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Mr. Shmulik Adler. Director of Regulatory Affairs, Brainsway Ltd.
ClinicalTrials.gov Identifier: NCT01361815     History of Changes
Other Study ID Numbers: CTP-0002-00
Study First Received: May 26, 2011
Last Updated: May 26, 2011
Health Authority: United States: Food and Drug Administration
Israel: Ethics Commission
Canada: Health Canada
Germany: Ethics Commission
France: Institutional Ethical Committee

Keywords provided by Brainsway:
Depression
MDD
SSRIs
TMS

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Recurrence
Mood Disorders
Mental Disorders
Behavioral Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014